Study identifier:D1690C00049
ClinicalTrials.gov identifier:NCT03152084
EudraCT identifier:2016-002961-79
CTIS identifier:N/A
DAPASALT: An Open Label, Phase IV, Mechanistic, Three-Arm Study to Evaluate the Natriuretic Effect of 2-Week Dapagliflozin treatment in Type 2 Diabetes Mellitus Patients with Either Preserved or Impaired Renal Function and Non-Diabetics with Impaired Renal Function
Diabetes Mellitus, Type 2
Phase 4
No
Dapagliflozin
All
24
Interventional
18 Years - 80 Years
Allocation: Non-randomized
Endpoint Classification: Efficacy
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Verified 01 May 2021 by AstraZeneca
AstraZeneca
-
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: Arm 1 T2DM subjects with an eGFR (CKD-EPI) between ≥25 and ≤50 mL/min/1.73m2 at the Screening Visit. | Drug: Dapagliflozin The study consists of a 2-week, open label, dapagliflozin (10mg) treatment period. |
Experimental: Arm 2 T2DM subjects with an eGFR (CKD-EPI) between >90 and ≤130 mL/min/1.73m2 for patients aged 59 or younger, between >85 and ≤130 mL/min/1.73m2 for patients aged 60 to 69, and between >75 and ≤130 mL/min/1.73m2 for patients aged 70 or older at the Screening Visit. | Drug: Dapagliflozin The study consists of a 2-week, open label, dapagliflozin (10mg) treatment period. |
Experimental: Arm 3 Non-diabetic subjects with an eGFR (CKD-EPI) between ≥25 and ≤50 mL/min/1.73m2 at the Screening Visit. | Drug: Dapagliflozin The study consists of a 2-week, open label, dapagliflozin (10mg) treatment period. |